This invention relates to prosthetic heart valves, and more particularly to surgically-implanted prosthetic heart valves.
There is increasing interest in prosthetic heart valves that use tissue material for the leaflets of the valve. Such valves tend to be less thrombogenic than mechanical prosthetic heart valves. This can reduce or eliminate the need for a patient who has received such a prosthesis to take anti-coagulant medication on a long-term basis. Tissue-based heart valves may also have other advantages, such as quieter operation. Because of the interest in such valves, improvements to them are greatly desired. Improved methods of making such valves are also sought.
Despite the various improvements that have been made to prosthetic heart valves, conventional devices, systems, and methods suffer from some shortcomings. For example, in certain procedures, prosthetic heart valves may be implanted in a native valve annulus without first resecting the native valve leaflets. The valves may have critical clinical issues because of the nature of the stenotic leaflets that are left in place. Additionally, it may be difficult or impossible to treat patients with uneven calcification, aortic valve bi-cuspid disease, and/or valve insufficiency with the current designs.
The reliance on evenly calcified leaflets could lead to several problems such as: (1) perivalvular leakage (PV leak), (2) valve migration, (3) mitral valve impingement, (4) conduction system disruption, (5) coronary blockage, etc., all of which can have severely adverse clinical outcomes. To reduce these adverse events, the optimal valve would seal and anchor adequately within the native valve annulus without the need for excessive radial force, protrusion into the left ventricular outflow tract (LVOT), etc., that could harm nearby anatomy and physiology.
There therefore is a need for further improvements to these prosthetic heart valves, as well as to the systems and methods for implanting these prosthetic heart valves. Among other advantages, the present invention may address one or more of these needs.